The United States Food and Drug Administration (FDA) has granted Fast Track Designation to Kintara Therapeutics’ (NASDAQ:KTRA) lead drug candidate VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM).
Kintara is currently advancing VAL-083 AGILE clinical study in the phase 2/3 trial to support the development and commercialization of VAL-083 in glioblastoma (GBM).
Robert E. Hoffman, President and CEO, said, “We believe Fast Track Designation is indicative of VAL-083's potential to improve outcomes for patients with GBM, the most aggressive form of brain cancer, Fast Track Designation allows us to work closely with the FDA and may expedite our commercial launch of VAL-083, if approved.”
The company anticipates top-line data readout from the international registrational phase 2/3 GBM AGILE Study around the end of calendar year 2023.
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Kintara Therapeutics shares are trading higher 37 percent at $0.26 in the pre-market session.
